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FDA 510(k) Application Details - K960519
Device Classification Name
Endoscopic Injection Needle, Gastroenterology-Urology
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510(K) Number
K960519
Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Applicant
MARTECH MEDICAL PRODUCTS, INC.
1500 DELP DR.
HARLEYSVILLE, PA 19438 US
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Contact
DAVID ROBERTS
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Regulation Number
876.1500
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Classification Product Code
FBK
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More FDA Info for this Product Code
Date Received
02/05/1996
Decision Date
05/01/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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